Case Study 6: CRO Handover - Team Integration - Sister ProtocolsThe Challenge For two sister protocols, BELTAS needed to manage the transition of the start up phase of a multi-national Phase III study from another CRO - always a delicate exercise. Following this, the sponsor requested we conduct the study across Australia and New Zealand with the inclusion of their CRAs alongside our own. The Response 1. We participated in weekly teleconferences and ongoing communication between sponsor, the outgoing CRO and sites, to ensure excellent communication and no tasks/issues were omitted in the transition. 2. BELTAS SCRAs worked closely with the other CRAs at joint site initiation visits to ensure site staff received adequate training, and that instructions for procedures were consistently delivered. 3. Regular communication took place between BELTAS SCRAs and the sponsor to ensure targets were being met and any issues were escalated as necessary. The Results . Excellent relationships with site staff, despite the transition from another CRO . The sponsor was pleased with BELTAS updates on study progress and issues . A close relationship was forged between the sponsor's CRA and BELTAS' SCRA to ensure sponsor requirements are being met . Patient recruitment was ahead of sponsor targets and all data monitored and entered within timelines Client Feedback "Great news re end of recruitment for the study!! Thanks to [the BELTAS team] for all your hard work" "BELTAS reports were all finalized within given timelines. Thank you very much." "Not only did we do it --- we beat our original goal and plan by 8 weeks and our stretch goal by 4 weeks!!!! The road has been really challenging at times I know, but thank you all for your sustained focus, your incredible determination, your 'can do' attitude, your tireless work ethic and your continued unwavering commitment to take on mission impossible. You are a world class team that just pulled off a world class performance!"
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"Not only did we do it --- we beat our original goal and plan by 8 weeks and our stretch goal by 4 weeks!!!! " - Client Global Clinical Program Manager |
